CAPÍTULO VIII: ANÁLISIS DE IDONEIDAD DE LOS PRESUPUESTOS
4. PROYECTO DE LEY
Excluded studies
Study Bipolar Olanzapine, Systematic RCT? Economic Reason for exclusion acute quetiapine review? evaluation?
manic or valproate episode? semisodium?
Allen, 199872 Yes Yes No No No Case report
Angst, 20011 No No No No No Guidelines for efficacy trials in
bipolar disorder
Anon., 200073 No No No No No Brief company report
Anon., 199474 Yes Yes No No No Report of results of Bowden 1994
Anon., 200175 Yes Yes No No No Non-systematic review of disodium
valproate (Depakote)
Anon., 199576 Yes Yes No No No Non-systematic review of drugs for
acute mania
Baetz, 199877 No Yes No Yes No People with panic disorder and
mood instability. N= 10
Baker, 200278 No Yes No Yes No Non bipolar mania participants
Baker, 200079 Yes Yes No No No Non-systematic review
Baker, 200180 Yes Yes No No No Non-systematic review
Baker, 200081 Yes Yes No No No Non-systematic review
Baker, 199782 Yes Yes No No No Critique of an economic model of
valproate semisodium (Keck 1996)
Bares, 200083 Yes Yes No No No Non-systematic review of
olanzapine use in mood disorders. In Czech
Berney, 199984 Yes No No No No No control group. Does not state
whether sodium or semisodium valproate
Beyzarov, 200085 Yes Yes No No No Report on olanzapine receiving a
licence for bipolar mania
Bhana, 200186 Yes Yes Yes No No Review
Bowden, 199787 No Yes No No No Discusses methodology of long-
term maintenance studies in bipolar disorder
Bowden, 199688 Yes No No No No Non-systematic review of dosing
strategies
Bowden, 200089 No Yes No Yes No Maintenance treatment not mania
Bowden, 199490 Yes Yes No No No Letter, reply to critique of Bowden
1994
Brasfield, 199991 No Yes No No No Economic study but not acute
mania, timescale unclear
Brown, 200292 No Yes No No No Letter to editor
Brown, 200193 No Yes No No No Not specifically acute mania, no
control group
116
Study Bipolar Olanzapine, Systematic RCT? Economic Reason for exclusion acute quetiapine review? evaluation?
manic or valproate episode? semisodium?
Calabrese, 200194 No Yes No No No Non-systematic review of rapid
cycling bipolar disorder
Calabrese, 199595 Yes No No No No Retrospective chart review of
adverse effects. Does not say whether valproate sodium or semisodium
Carroll, 200196 Yes Yes No No No Non-systematic review of loading
strategies in acute mania
Cavazzoni, 200297 Yes Yes No No No Non-systematic review
Chou, 199298 Yes No No No No Non-systematic review of drug
treatments for acute mania, out of date
Conney, 199999 Yes Yes No No No Retrospective review of geriatric
patients treated with lithium or valproate semisodium.
Cookson, 2001100 Yes Yes No No No Non-systematic review
Dalkilic 2000101 Yes Yes No No No Serbian, probably not RCT
Daly, 19975 Yes No No No No Non-systematic review
Dardennes, 1997102 Yes Yes No No No Critique of a pharmacoeconomic
study58
Das Gupta, 200216 No No No No No Non-systematic review of
economic costs of bipolar disorder (not mania)
David, 2002103 No Yes No Yes No Non-manic participants
Davis, 1993104 Yes Yes Yes No No A systematic review that includes
only one trial of interest, i.e. Pope 199148
Dinan, 20023 Yes Yes No No No Letter
Dose, 1995105 Yes No No No No Non-systematic review of drug
treatments for acute mania
Dunayevich, 2001106 Yes Yes No No No No control group
Dunayevich, 2000107 Yes Yes No No No Case report
Dunayevich, 2000108 Yes Yes No No No Non-systematic review of atypical
antipsychotics in bipolar disorder
Ellenor, 1995109 No Yes No No No Non-randomised trial including
non-manic patients
Emrich, 1983110 No No No No No Non-systematic review of opioids
in the treatment of depression and mania
Falsetti, 1999111 No Yes No No No Non-systematic review of efficacy
of olanzapine in schizophrenia
Feldstein, 1995112 No Yes No No No Short report on price change of
Depakote
Fellows, 2001113 No Yes No No Yes Non-manic participants
Frankenburg, No Yes No Yes No Not acute mania, people with
2002114 borderline personality disorder and
comorbid bipolar II received the drug for 6 months
Frazier, 2000115 Yes Yes No No No Non-randomised trial
117
Study Bipolar Olanzapine, Systematic RCT? Economic Reason for exclusion acute quetiapine review? evaluation?
manic or valproate episode? semisodium?
Frazier, 2000116 Yes Yes No No No Non-RCT
Frye, 1996117 Yes Yes No No No Non-RCT
Freeman, 1992118 Yes No No Yes No Think it is about sodium valproate,
not valproate semisodium
Garza-Trevino, Yes No No No No Non-systematic review of drugs for
1998119 acute mania. Out of date
Geddes, 2001120 Yes No No No No Methodology
Gerner, 1992121 Yes No No No No Does not look at any drugs of
interest
Ghaemi, 2000122 Yes Yes No No No Non-systematic review of atypical
antipsychotics in bipolar disorder
Ghaemi, 1999123 No Yes No No No Non-randomised trial with non-
manic patients
Ghaemi, 1999124 No Yes No No No Erratum message relating to
Ghaemi and Katzow125
Goldberg, 1999126 No No No No No Economics paper – sodium not
semisodium
Goodwin, 1994127 Yes No No No No Non-systematic review of drug
treatments in mania
Haddad, 1999128 Yes Yes No No No Two case reports
Hamilton, 2000129 No Yes No No No Newspaper question and answer
article
Hellewell, 2000130 Yes Yes No No No Non-systematic review of
antipsychotics in all stages of bipolar disorder
Hilger, 2002131 No Yes No No No Non-systematic review
Hilty, 1999132 No No No No No Not a systematic review (despite
MEDLINE search), of bipolar disorder among adults, all aspects
Hirschfeld 1999133 Yes Yes No No Yes Arrived too late
Icovino, 1994134 No Yes No No No Not acute mania (assessed over
18-month period), not randomised
Jacobsen, 1995135 No Yes No No No Non-randomised trial with non-
manic patients
Jagadheesan, 2002136 No No No No No Commentary
James, 2001137 No No No No No Non-systematic review of
treatments for bipolar disorder
Janicak, 1992138 Yes No No No No Non-systematic review of
treatments for mania and related disorders (not of olanzapine, quetiapine or valproate semisodium)
Jann, 1984139 Yes No No No No Non-systematic review on drug
treatments for mania. Out of date
Janowsky, 1999140 Yes Yes No No No Report of a conference abstract,
olanzapine vs placebo, Tohen 199935
Jonnalagada, 2000141 Yes Yes No No No Two case reports of acute dystonia
with quetiapine
118
Study Bipolar Olanzapine, Systematic RCT? Economic Reason for exclusion acute quetiapine review? evaluation?
manic or valproate episode? semisodium?
Kafantaris, 1995142 No No No No No Non-systematic review of
treatment of bipolar disorder in children and adolescents. No controlled studies of acute mania
Kafantaris, 2001143 Yes No No No No Non-randomised and non-target
intervention
Kaiser, 2002144 Yes Yes No No No Pooled indirect comparisons
presenting within-group treatment response to placebo, valproate semisodium and olanzapine
Keck, 2002145 Yes Yes No No No Non-systematic review
Keck, 1996146 Yes Yes No No No Non-systematic review of drug
treatments for bipolar disorder
Keck, 1996147 Yes No No No No Discussion paper of the issues
related to health economic issues associated with antimanic agents
Keck, 1999148 Yes Yes No Yes No Arrived too late
Keck, 2000149 Yes No Yes No No Examines the placebo effect within
RCTs of acute bipolar mania
Keck, 2000150 Yes Yes No No No Non-systematic review of
antipsychotics in mood disorders and risk of tardive dyskinesia
Keck, 2000151 Yes Yes No No No Non-systematic review
Kennedy, 2001152 No Yes No No No Technical non-systematic review of
olanzapine in the elderly. Unclear what diagnosis they were looking at
Kerwin, 2002153 Yes Yes No No No Commentary on Ref. 42
Ketter, 2000154 No No No No No Non-randomised study
investigating markers/predictors of divaproex response
Kravitz, 1994155 Yes Yes No No No Letter, critique of Ref. 49
Kupka, 2001156 Yes Yes No No No Non-systematic review
Lacerda, 2002157 Yes Yes No No No Non-systematic review
Lemoine, 2000158 No No No No No People with remitted recurrent
bipolar or unipolar disorder. Valpromide
Levine, 2000159 Yes Yes No No No Case report
Licht, 1998160 Yes Yes No No No Non-systematic review of mania
treatment
Licht, 2000161 Yes Yes No No No Non-systematic review of drug
treatment with antipsychotics for mania
Licht, 2001162 Yes No No No No Discusses the methodological
problems associated with randomised trials evaluating drug effects in mania
Madhusoodanan, Yes Yes No No No Non-systematic review of
2001163 olanzapine in psychotic elderly
119
Study Bipolar Olanzapine, Systematic RCT? Economic Reason for exclusion acute quetiapine review? evaluation?
manic or valproate episode? semisodium?
Masand, 2000164 Yes Yes No No No Non-RCT
Maggi, 2001165 No Yes No No No Retrospective study of 15 patients
with HIV-associated mania and the effects of valproate semisodium on viral load
Martinez, 1998166 Yes Yes No No No Retrospective chart review
McClellan, 1997167 No No No No No Non-systematic review of
assessment and treatment of children and adults with bipolar disorder
McElroy, 2000168 Yes Yes No No No Non-systematic review
McElroy, 199560 Yes No No No No Non-systematic review
Mehnert, 2001169 No Yes No No No Non-manic participants
Miller, 2001170 Yes Yes No No No Chart review
Milton 2001171 Yes Yes No No No Pooled analysis from RCTs, not
referenced
Müller- Yes No No Yes No Examines the effectiveness of
Oerlinghausen, sodium valproate
1998172
Müller- Yes No No Yes No Sodium valproate, not semisodium
Oerlinghausen, 2000173
Namjoshi, 2002174 Yes Yes No Yes Yes Follow-up data
Namjoshi, 2000175 No Yes No Yes No Non-manic patients
Namjoshi, 2000176 Yes Yes No Yes No Not acute phase
Namjoshi, 2000177 Yes Yes No Yes No Not acute phase
Namjoshi, 1999178 No Yes No Yes No Bipolar disorder generally, rather
than mania associated with bipolar disorder
Namjoshi 2001179 Yes Yes No Yes No Non-manic patients
Noaghiul, 1998180 Yes Yes No No No No control group
Ozcan, 1999181 Yes Yes No No No Turkish, non-RCT
Ozcan, 2001182 Yes No No Yes No Examines the effectiveness of
sodium valproate and not valproate semisodium
Papatheodorou, Yes Yes No No No Preliminary report of a non-
1993183 randomised trial
Paptheodorou, Yes Yes No No No No control group
1995184
Piepho, 2002185 No Yes No No No Non-systematic review on cardiac
side-effects of antipsychotics – may be useful for adverse effects?
Poolsup, 2000186 Yes No Yes No No Evaluates the effectiveness of
lithium
Post, 1997187 Yes Yes No No No Guidelines on algorithms for
treatment of mania
Price, 2000188 Yes Yes No No No Short non-systematic review of
olanzapine in acute mania
120
Study Bipolar Olanzapine, Systematic RCT? Economic Reason for exclusion acute quetiapine review? evaluation?
manic or valproate episode? semisodium?
Procyshyn, 1998189 No Yes No No No Non-randomised trial including
non-manic patients
Reddy, 2000190 No No No No No Non-systematic review of bipolar
disorder in young people
Rossler, 2001191 No No No No No Not relevant intervention
Sachs, 2000192 Yes No No No No Treatment guidelines
Sachs, 2002193 Yes No No Yes No Non-relevant intervention
Sajatovic 1997194 Yes Yes No No No Serbian, probably not RCT
Sanger, 1998195 Yes Yes No No No Non-RCT
Sanger, 1999196 Yes Yes No Yes No Continuation phase after acute
phase RCT, no relevant outcomes
Sanger, 2001197 No Yes No No No Continuation phase of an included
RCT;35all patients were given
olanzapine
Sanger, 1998198 No Yes No Yes No Patients were rapid-cycling rather
than manic
Schneider, 2001199 Yes Yes No No No Commentary on Ref. 89
Schwartz, 2000200 Yes Yes No No No Retrospective chart review
Segal, 2000201 Yes Yes No No No Non-systematic review of drugs for
mania
Shi, 2002202 Yes Yes No Yes No Long-term data only, not acute
phase
Solomon, 1995203 No No No No No Non-systematic review of long-
term treatments for bipolar disorder
Solomon, 1997204 No Yes No Yes No Continuation and maintenance
treatment, not acute mania
Steffens, 1996205 Yes No No No No Decision model for acute
treatment of mania – does not list olanzapine, quetiapine or valproate semisodium
Strakowski, 2001206 Yes Yes No No No Non-systematic review of drugs for
bipolar disorder
Swann, 2001207 Yes Yes No No No Acute phase not randomised.
RCT of continuation phase (not acute)
Tohen, 2002208 No Yes No Yes No Non-manic participants
Tohen, 2001209 No No No No No Non-systematic review of
antipsychotic agents in the treatment of patients with bipolar disorder, and not mania only
Tohen, 2001210 No Yes No Yes Yes Participants with schizoaffective
disorder
Tohen, 2002211 No Yes No Yes No Patients were not currently
experiencing a manic episode
Tohen, 1998212 Yes Yes No No No Non-systematic review of
antipsychotics in bipolar affective disorder
121
Study Bipolar Olanzapine, Systematic RCT? Economic Reason for exclusion acute quetiapine review? evaluation?
manic or valproate episode? semisodium?
Tohen, 2000213 Yes Yes No No No A non-systematic review of onset
of action of antipsychotics in the treatment of mania
Tohen, 1999214 Yes Yes No No No Non-systematic review of
treatments for acute mania
Tohen, 2001215 Yes Yes No No No Commentary (in Spanish?) on
Ref. 36
Tohen, 2002216 Yes Yes No No No Letter
Toren, 1998217 No Yes No No No Non-systematic review of atypical
antipsychotics in child and adolescent psychiatry
Townes, 1997218 Yes No No No No Letter, critique of a study
comparing lithium and valproic acid
Vasudev, 2000219 Yes No No Yes No Carbamazepine vs sodium valproate
Woods, 2000220 No No No No Yes Non-systematic review of the
economic burden of bipolar disorder (not mania)
Woods, 1998221 Yes No No No No Letter to editor
Yatham, 1997222 No No No No No Non-systematic review of
treatments for bipolar depression
Young, 2000223 No Yes No Yes No Treatment of bipolar depression
(not mania) with valproate semisodium
Zarate, 1999224 Yes Yes No No No Retrospective study of patient
records, valproate semisodium vs valproic acid. Majority had bipolar affective disorder but there were other diagnoses. Could be useful for adverse events
Zhu, 2001225 No Yes No Yes Yes Data for maintenance rather than
Clinical effectiveness data
Clinical effectiveness data were extracted and entered into a Microsoft Access form under the headings given below. In the following lists, [ ] indicates a list of options included in a pull-down box, ( ) indicates a click on/off button, where on represents ‘yes’ and off ‘no’, and { } indicates free text entered in a box.Study details
● name of trial {trial name, I.D. or ‘not stated’} ● endnote reference {endnote reference
number}
● primary source [database, handsearching,
company submission]
● author {i.e. Jones et al.}
● date {i.e. year of publication or date of interim
data collection}
● type of report [abstract, full manuscript, interim
report]
● comparison group included [placebo,
alternative drug, unclear, not stated]
● intervention {i.e. drug(s) name(s)} ● dose of intervention {dose} ● length of intervention {length}
● comments about interventions {summary of
comments or ‘none’}.
Participants
● disease status [ICD, DSM, not stated]
● previous treatment {summary of drugs or other
treatments, or ‘not applicable’}
● age or age range of participants {age(s)} ● other participant characteristics {summary of
characteristics}
● comments about participants {summary of
comments or ‘none’}.
Numbers in conditions
● number recruited or accrued {summary or ‘not
stated’}
● length of follow-up after treatment finishes
{summary or ‘not stated’}
● number and times of follow-up measurements
{summary or ‘not stated’}
● attrition intervention {summary of number
involved and reasons for loss}
● per protocol analysis performed [yes, no, not
stated, unclear]
● comments {summary of comments or state
‘none’}.
Results (data for all outcomes specified
in the protocol will be entered in the
following format)
● outcome 1 {description of outcome measure} ● intervention 1 baseline data {data for
outcome 1}
● intervention 2 baseline data {data for
outcome 1}
● intervention 1 follow-up data {data for
outcome 1}
● intervention 2 follow-up data {data for
outcome 1}
● comments on outcome 1 {summary of
comments}
● overall comments {summary of comments}
Economic evaluation data
Economic evaluation data were extracted and entered into an Access form under the headings given below.● endnote reference {in the form of xyz,
no ‘#’}
● primary source [database, handsearching,
company submission]
● author {i.e. Jones et al.}
● date {i.e. year of publication or date of interim
data collection}
● type of economic evaluation [cost-effectiveness
analysis, cost–utility analysis, cost–benefit analysis]
● currency used [$US, $AS, £Sterling … , not
stated]
● year to which costs apply {enter year or not
stated}
● perspective used {e.g. health service,
societal, hospital, third-party payer, patient, unclear}
● study population {describe the population
characteristics}
● intervention 1 {description of intervention 1} ● intervention 2 {description of intervention 2} ● source of effectiveness data [single study,
review/synthesis of previous studies, expert
opinion, not stated] 123